vela®

Every 7 seconds, a woman or a newborn loses their life during pregnancy or childbirth due to preventable or treatable causes. Nearly 70% of all these deaths occur in Sub-Saharan Africa, showing a significant disparity in access to quality healthcare. Prolonged labour is an important contributing factor to maternal and newborn mortality, despite the existence of vacuum extraction, a proven intervention widely used in high-income countries.

In Sub-Saharan Africa vacuum extraction usage remains as low as 1% compared to 8% in the Netherlands. Increasing vacuum extraction utilisation in Sub-Saharan Africa has a significant potential to improve maternal and neonatal outcomes. Research conducted in Ugandan hospitals underscores this potential, revealing a remarkable 23.6% reduction in stillbirth rates with a modest increase in vacuum extraction usage from 0.6% to 2.6%. Moreover, vacuum extraction emerges as a safer and more cost-effective alternative to caesarean sections in resource-constrained settings, significantly reducing health complications for both mothers and infants while requiring fewer healthcare resources. Despite these benefits, the widespread implementation of vacuum extraction in Sub-Saharan Africa remains a challenge due to their high cost per-use and dependency on supply networks. As a result, hospitals in low-resourced settings often only have access to vacuum extraction by reusing disposable devices or using outdated and complex reusable devices. This leads to unnecessarily high risks of infection, device failure during use, or in the worst case to not being able to perform the procedure at all. 

Moreover, the widespread use of disposable vacuum extractors globally results in 3 to 5 million discarded devices, significantly impacting the environment and posing a threat to the health of future generations. In response, Gynaecologists in the Netherlands have initiated efforts like Gynae Goes Green to address the environmental implications of disposable medical devices. Similarly, healthcare professionals in European countries like Belgium, England, Sweden, and Denmark, are transitioning from disposable to reusable equipment. Therefore, the disposable design of current vacuum extraction devices not only leads to unnecessary maternal and neonatal deaths, but also contributes to the growing medical waste and CO2 emissions of the healthcare industry.

LAYCO has developed vela®, an innovative reusable vacuum extractor engineered with accessibility and sustainability as design principles. Developed in close collaboration with approximately 200 gynaecologists, vela® prioritises simple use and safety. Its operation is similar to traditional vacuum extractors, featuring a universal cup that securely attaches to the baby's head using vacuum pressure. This design allows a seamless integration into existing obstetric practices without adding complexity to the vacuum extraction procedure.  

What sets vela apart is its remarkable durability allowing for 100 uses. Its reusability leads to a significant reduction of 40% in CO2 emissions and 98% in waste compared to disposable alternatives. Additionally, vela® utilises patented technology that integrates pressure valves, pressure release, and pressure indicators into a single component called ‘VIR’, streamlining the design to just 5 components compared to the conventional 25 components. As a result, the sterilisation process becomes simpler, minimising infection risks and enhancing safe usage, especially in low-resourced settings. Moreover, vela® is manually operated by a single practitioner, reducing the resources needed to be operated such as electricity and extra personnel. The combination of these features makes vela® a durable tool, promoting environmental stewardship for generations to come and ensuring global access to a long-term solution for all mothers and babies.

Our solution vela®, serves stakeholders involved in prolonged labour where assisted vaginal delivery is needed. This includes gynaecologists, obstetricians, midwives, and other healthcare providers involved in maternal and neonatal care, and of course the expectant mothers facing childbirth complications, especially in low-resourced settings.

For gynaecologists and obstetricians, vela® addresses the usability challenges associated with current reusable options, which often require the assistance of two or three practitioners. The simplification of the vacuum extraction procedure is thanks to the vela® design that integrates single-user manual operation with a quick pumping mechanism. Additionally, vela® offers assurance to professionals regarding the procedure safety, as it is designed to be easily disassembled for effective cleaning and sterilisation. In addition to usability improvements, vela® contributes significantly to reducing the environmental impact associated with disposable devices, aligning with hospitals' and doctors’ sustainable efforts. A comprehensive life cycle assessment (LCA) positions vela® as the most sustainable vacuum extractor on the market, with a remarkable reduction of approximately 40% in CO2 equivalent emissions and a 98% reduction in waste per vacuum extraction compared to standard disposable alternatives like the Kiwi vacuum extractor.

For expectant mothers, vela® represents a safer and more cost-effective alternative during prolonged labour, with lower risks of childbirth-related complications than caesarean sections. This is particularly important for mothers in low-resourced settings, where vacuum extraction is not widely available and accessing a caesarean section can be risky and financially burdensome. Research indicates that using vacuum extraction instead of caesarean sections can reduce childbirth-related deaths and uterine ruptures, which are major contributors to maternal mortality. In addition to reducing mortality risks, vela® also helps mothers recover more quickly after childbirth and lowers the risk of birth-related disabilities. Therefore, LAYCO aims to improve the lives of mothers and babies by providing vela® at a discounted price to countries where maternal and neonatal mortality rates fall behind the Sustainable Development Goals set by the United Nations. In this way, vela® expands global access to vacuum extraction procedures, making childbirth safer for mothers and babies worldwide.

LAYCO's journey began in 2020 within the Technical University of Delft's "Surgery for All" research group, where our co-founder Dieuwertje's internship in a Kenyan public hospital sparked her passion for innovative reusable medical devices. With a vision to make a difference, Dieuwertje inspired Thom Weustink, whose expertise in business development and deep connection to the African continent complemented the team's objectives. Since then, LAYCO has secured financial support from various organisations, including the Netherlands Enterprise Agency (RVO), the Dutch Research Council (NWO), and a convertible loan from the Rabobank and the Innovation Fund North Holland, amounting to 750K euros in investments. 

Our team comprises engineers with a passion for medical innovations for resource-constrained and a deep understanding of global health challenges. The team is supported by an advisory board consisting of expert gynaecologists in global health, including Barbara Nolens, Thomas van den Akker, and Steven Gwer, alongside Professor Jenny Dankelman and sales advisor Jacqui Hart. 

In the last 2 years, we have co-created vela® through extensive testing and feedback sessions from over 200 end-users in Europe and Africa. This proximity with the real users has allowed us to fine-tune the design and functionality of vela® and ensure its safety and usability in real-world settings. We work closely with sterilisation department experts from St. Antonius Hospital in the Netherlands to make sure that vela® is easy to clean and to be safely used. We have also validated the usability of vela® with gynaecologists and midwives from the Netherlands, Kenya, and Uganda. During a visit to 9 hospitals in Uganda in January 2024, 21 midwives found vela® easy to disassemble and assemble, while 15 local experts confirmed its cleanability. In our most recent study involving 80 gynaecologists from 7 Dutch hospitals, vela® performed at golden standard level, with 95% of participants expressing a willingness to replace their disposables with vela®, highlighting sustainability as a key factor.

In addition, we have built strong relationships with key organisations at the forefront of scaling maternal and neonatal care in LMICs. These include leading wholesalers such as IDA Foundation, Medical Export Group, Imres, and MissionPharma, all of whom have expressed their intent to purchase vela® with the signing of official pre-agreements. We have also engaged with NGOs leading maternal and neonatal health projects in Uganda and India, such as Jhpiego, Amref, and PATH, who recognize the potential of our solution. Together we force partnerships that enable us to set-up implementation, training and research projects with a local team of experts to ensure sustainable adaptation going forward. Cooperating together will lead to valuable insights into the needs and preferences of healthcare providers and facilities in LMICs as well as scale our impact to reach more mothers and babies in low-resourced settings.

Currently, vela® is at Technical Readiness Level (TRL) 5, marking the final stage of prototyping for LAYCO. During this phase, the design has been optimised through various validation studies. Firstly, vela® underwent validation for reusability in collaboration with two cleaning departments in Kenyan hospitals and the sterilisation department at St. Antonius Hospital. This process identified two areas for design optimization, which are currently being addressed. Additionally, a manikin study was conducted in partnership with six different Dutch hospitals to compare vela® with the disposable variant (Kiwi Omnicup) and assess its performance. Although vela® performed at golden standard, two adjustments are being made to further optimise usability during operation. Furthermore, to guarantee vela®'s resilience to high traction forces and ensure biocompatibility, LAYCO conducted exhaustive material research. The material has been rigorously tested through 100 usage and reprocessing cycles, employing various methods such as bleach, glutaraldehyde, and autoclaving. In collaboration with TU Delft, potential forces acting on vela® during usage were digitally modelled. This force modelation allowed LAYCO to identify potential failure points and improve the design for robustness. Overall, vela® is undergoing rigorous testing and optimisation to ensure its effectiveness, safety, and usability before moving forward into the production and pilot phases.

With our innovation, vela®, we aim to ensure equitable access to quality healthcare worldwide. By participating in Solve, we aspire to establish valuable connections with professionals and organisations operating within the maternal health sector. Additionally, we seek to acquire expertise and assistance in engaging with international partners active in global health initiatives in low- and middle-income countries (LMICs). Furthermore, we seek financial support to continue the development of vela®. Collaboration with Solve will help us save maternal and neonatal lives all around the world and make a meaningful impact on global health equity in obstetric care with vela®.

Our solution, vela®, stands out for offering an improved vacuum assisted delivery approach for emergency obstetric care. Unlike traditional vacuum extractors, vela® is the first reusable device designed for single-user operation, significantly reducing waste while enhancing safety and usability, particularly in low-resource settings. Our solutions combines key features such as:

• Designed for reusability: The robust reusable design of vela® is engineered to endure at least 100 uses without compromising its performance. 

• Effortless set-up: the smart design reduces components and enables seamless assembly  and disassembly for easy reuse.

• Single-User Operation: vela® allows manual operation by a single practitioner, granting flexibility and shorter intervention times.

• Eco-Conscious Design: With reduced waste and CO2 emissions compared to disposable alternatives, vela® promotes environmental sustainability.

• Cost reduction: By combining reusability and a differentiated pricing strategy, vela® makes quality vacuum extraction cost-effective and accessible to all. 

• Single-cup for all positions: With vela®, practitioners can perform vacuum extractions from various foetal positions with one single cup. No need for extra accessories or cups.

• Patient friendly: Expecting mothers experience a comfortable birth atmosphere with the gentle, noiseless, and metal-free design of vela®. 

• High-quality: The combination of Dutch cutting-edge engineering and high industry standards ensures top-tier quality of vela®

With its innovative features, vela® improves the management of obstructed labour, offering a pathway towards reducing maternal and neonatal deaths in low-resourced settings. Moreover, vela® seeks to promote the widespread adoption of reusable medical devices among end-users and healthcare facilities. This has the potential to transform the healthcare business, which is now dominated by disposables, and motivate manufacturers in the industry to prioritise sustainability and accessibility in the design of their products.

Our solution vela® is designed to address the critical issues hindering accessible and sustainable maternal care during obstructed labour. So far, we have secured funding for research and development; assembled a team with expertise in biomedical engineering; and gathered knowledge from established OB/GYNs and midwives. Furthermore, we are establishing partnerships with healthcare distributors in target regions. 

With these inputs, we are progressing towards producing vela®, our reusable vacuum extractor currently in the prototyping phase. Complementing the device, we aim to provide comprehensive training to users on the effective and safe performance of vacuum extractions with. Our device and training materials are being designed with the knowledge and expertise of end-users from high- and low-resourced settings to ensure its easy implementation in the current practices. In addition, our sales and distribution team ensures that our device is sold with a differentiated pricing, favouring countries that have not achieved the SDG 3 related to maternal and neonatal mortalities with a discounted pricing. 

These activities will result in two tangible outputs. First, healthcare workers with the skills to perform safe vacuum extractions in obstetric emergencies. Second, a reduction in procurement costs for vacuum extraction medical devices in resource-limited settings. 

Immediate outcomes in the well-being of mothers are expected as healthcare professionals will be able to offer a safer alternative to caesarean sections in cases of obstructed labour. Studies show that vacuum extraction reduces the risk of stillbirths and uterine rupture in mothers compared to other interventions. Moreover, mothers who undergo vacuum extraction are likely to experience less pain and shorter recovery periods compared to caesarean sections. These immediate outcomes not only benefit mothers but also have significant implications for their families in the intermediate term. The reduced risks associated with vacuum extraction translate into lower out-of-pocket costs, providing financial relief. Studies indicate that the average in-hospital and post-discharge follow-up costs of caesarean sections in sub-Saharan Africa can push families into impoverishment in some cases.

Other immediate change is reflected in healthcare facilities. The implementation of vela® is expected to enhance the capacity of healthcare facilities where caesarean sections are the standard procedure for obstructed labour. Healthcare facilities will have the ability to save personnel, time, and resources during second-stage labour compared to caesarean sections and more efficiently manage obstetric emergencies. Additionally, the adoption of vela® will immediately reduce the medical waste and CO2 emissions produced in a labour ward in healthcare facilities. This reduction is attributed to the results of an initial Life Cycle Analysis in which vela® was identified as the most sustainable option of the market with a 40% reduction in CO2 emissions and a 98% reduction in medical waste.

As vela® continues to gain acceptance, we anticipate a decline in maternal and neonatal mortality rates associated with obstructed labour. Additionally, hospitals are likely to transition from disposable to reusable devices. These changes in practice, together with better maternal and neonatal outcomes, will eventually promote sustainable and accessible emergency obstetric treatment for all women.

Our impact goals for vela® are aimed at achieving three primary objectives:

• Reducing maternal and neonatal mortality rates: Our first goal is to decrease maternal and neonatal mortality rates associated with obstructed labour, particularly in low-resourced settings. To measure this, we will closely monitor changes in mortality rates in regions where vela® is implemented, comparing them to baseline data to assess the impact of our solution.

• Ensuring equitable access to emergency obstetric care: Our second goal is to ensure equitable access to emergency obstetric care by increasing the availability of vela® units in healthcare facilities in low-resourced settings. Therefore, we will track the number of healthcare personnel trained for safe vacuum extraction with vela® and the active vela® units in these facilities. In this way we can measure the extent to which vela® have contributed to improving access to essential obstetric services and devices.

• Promoting sustainable healthcare practices: The second goal focuses on promoting sustainable healthcare practices by reducing CO2 emissions and medical waste in the obstetric field. Healthcare facilities adopting vela® as an alternative to disposable vacuum extractors will be provided with an impact calculator. This tool will enable end-users to submit data related to their use of vela® and calculate the total CO2 emissions and kilograms of waste saved. We will collect this data and estimate the environmental impact of vela®.

The core technology powering vela® represents an integration of advanced design, extended material research, innovative production techniques and an alternative pumping mechanism. LAYCO has successfully streamlined vela® into a compact system, comprising just a few essential parts and powered by the following key technologies: 

• VIR Component: LAYCO has achieved remarkable efficiency by consolidating multiple functions into a single component known as the ‘VIR.’ This innovative part facilitates airflow control, vacuum level indication, and post-usage vacuum release. Extensive research into material properties, flexible behaviours, and shape memory has enabled the development, validation, and optimization of the VIR design.

• Lubrication-Independent Pumping Mechanism: LAYCO has engineered a pumping mechanism that allows vacuum creation independently of lubrication, thereby minimising maintenance requirements. The design is developed in such a way that it is easily disassembled for reprocessing yet robust enough for regular use, ensuring sustained functionality.

• Reinforced Tube: A unique, easily detachable tube with high flexibility and airtight connections has been developed by LAYCO. Extensive research into production and assembly techniques, including extrusion, injection moulding, knotting, squeezing, chemical bonding, laser welding, mirror welding, and vulcanization, was conducted and a new production technique was developed to achieve this feature.

Our team comprises 5 full timers and 4 advisory organizations. 

Full time staff:

• Dieuwertje Drexhage - CTO & Co-founder
• Thom Weustink - CEO & Co-founder
• Christiaan Bakker - Innovation Lead
• Abe Kok - Test Engineer
• Camila Cuadrado -  Business Developer

Contractors:

• Helder Industrial Design: Prototyping and manufacturability.
• Muller Design: Prototyping and design.
• EP&C: Patent processes.
• Process Vision: Quality Assurance and Regulatory Affairs.

Our team has been actively developing our solution, vela®, for a total of 3 years. The initial concept for vela® was developed during our Innovation Lead's master graduation project in 2021 at the "Surgery for All" research group from the Technical University of Delft. LAYCO took over the project to further develop vela® in January 2022.

At LAYCO, diversity and inclusivity are at the core of our values and culture. Our team comprises individuals from various backgrounds, including different religious beliefs, cultural identities, and LGBTQ+ members. We value the unique perspectives and experiences that each person brings to the table hence we operate on a flat hierarchy, meaning that everyone's opinions and ideas are given equal importance and consideration. That is why we strive to create a diverse and inclusive team with different perspectives to ensure the best outcomes possible for all. Furthermore, we prioritise the professional development of our full-time team members, allocating budget for opportunities for growth such as workshops, events, and courses. Most importantly, we maintain a zero-tolerance policy towards discrimination of any kind, ensuring that our workplace is safe and welcoming for everyone.

LAYCO operates with a business-to-business strategy, targeting hospital and non-hospital organisations. The hospital segment comprises healthcare facilities like clinics and birth centres that provide emergency obstetric care. The non-hospital segment are organisations involved in building healthcare capacity through maternal health projects or distribution of medical equipment. 

To make vela available in target markets, LAYCO adopts a resale model through authorised distributors, optimising market entry with lower financial commitments. Engagements with distributors in Europe and International Aid Organizations, including IDA Foundation, IMRES, and the Medical Export Group, lay the foundation for revenue generation and leverage on their Key Opinion Leaders network and position in the market. 

Our value proposition centres around offering the most sustainable and user-friendly vacuum extraction device on the market that improves maternal and neonatal outcomes during prolonged labour. Feedback from over 20 distributors and 200 end-users across African and European countries confirm that vela® aligns with the preferences of these markets. In low and middle-income countries, customers emphasise the importance of user-friendliness and cost-effectiveness in vacuum extraction devices, while in high-income countries, sustainability and patient-friendliness take precedence. In this way, vela® distinguishes itself with its reusability, noiseless operation, and compact design, representing the ideal solution that addresses the limitations of disposable devices leading the market and the affordable bulky reusable models.

Additionally, our product is offered with a differentiating pricing strategy, enabling healthcare facilities to access vacuum extraction technology at discounted rates in countries where SDGs related to maternal and neonatal deaths have not been met. This approach aims to improve accessibility to cutting-edge obstetric technology in emerging markets while driving demand. In regions where SDGs have been achieved, vela® is competitively priced to capture market share from leading competitors such as Kiwi OmniCup.

To measure that our proposition brings value to our target customers we monitor the changes in mortality rates in LMIC regions where vela® is implemented, comparing them to baseline data to assess the impact of our solution. Additionally, we will measure the personnel trained with vela for safe vacuum extraction and the number of active vela® in order to see how much we have contributed to increase the access to emergency obstetric services and devices more. These measures will inform us how much value we are providing to the population we serve.

Our primary revenue stream comes from selling vela® to healthcare facilities and organisations involved in emergency obstetric care. Our differentiated pricing strategy ensures affordability in regions where Sustainable Development Goals (SDGs) have not been met, while also capturing market share in regions where SDGs have been achieved. We have conducted thorough pricing analyses, consulting with end-users and international aid organisations, resulting in two pricing tiers: €3,500 for markets with higher income and €500 for lower-resourced areas with high maternal and neonatal mortality rates. These prices are strategically set to align with market affordability thresholds while also ensuring a healthy profit margin for further investment in product development and medical personnel training.

Our revenue generation from vela® sales will begin in Q3 2025, aligning with our product launch. Initial focus lies on innovator and early adopter markets emphasising improved maternal and neonatal outcomes and sustainable procurement. The Netherlands, Uganda and India  are our primary targets in the first year, leveraging established partnerships with end-users and organisations for effective implementation. Further expansion targets high-volume markets, capitalising on success stories from initial markets, this includes Europe, Africa and the United States. The expansion will be achieved with an official local distribution network in the target countries. Initial discussions with distributors and humanitarian aid organisations have been promising, with commitments from seven European distributors and three major wholesale distributors to NGOs.

In addition to vela® sales, we are committed to offering comprehensive training services tailored to organisations and governments seeking to build healthcare capacity in emergency obstetrics. These training programs represent a secondary recurring revenue stream, offering diverse educational formats, including workshops, interactive simulations, and expert-led seminars. Through these trainings, participants will develop the essential skills and knowledge required to effectively manage prolonged labour and utilise vela® in emergency obstetric care scenarios. 

Additionally, we actively seek to secure grants and investment funding to support our research and development activities and market expansion efforts. For 2024 we are raising a seed round of 1 million euro in a consortium of distributors, production partners, impact and angel investors. Collaborations with non-profit organisations like Amref Uganda and PATH further enhance our access to additional grant opportunities. To date we have successfully secured: 

• Grants and subsidies that sum €710,000

• Rabobank Innovation Loan of €150,000

• Funds from Innovatiefonds Noord Holland of €300,000

• Albert Schweitzer price of €7,500

Our financial projections are based on validated assumptions and market research, ensuring the feasibility and viability of our revenue model. We anticipate selling 700 vela® units in high-income countries within the first three years and 2,000 units in low-resource settings. This translates to facilitating 20,000 safe deliveries in low-resourced settings by 2028 and replacing 67,000 disposables in high-income countries. By targeting both high-income and low- to middle-income countries, we aim to maximise revenue while advancing our social mission of improving maternal and neonatal outcomes worldwide.